Andexanet阿尔法对急性出血主要相关因素Xa抑制剂。
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Connolly SJ、铣削TJ Jr Eikelboom JW,吉布森厘米,Curnutte JT,黄金,布朗森医学博士陆G,康利PB, Verhamme P,施密特J, Middeldorp年代,科恩,Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J,古德曼,利兹J,恩斯提单,Siegal DM, Zotova E,米克斯B, Nakamya J, Lim WT,克洛泽M
Andexanet阿尔法对急性出血主要相关因素Xa抑制剂。
郑传经地中海J。2016年9月22日,375 (12):1131 - 41。doi: 10.1056 / NEJMoa1607887。Epub 2016年8月30日。
- PubMed ID
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27573206 (在PubMed]
- 文摘
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背景:Andexanet阿尔法(Andexanet)是一个重组改造人类因素Xa诱饵蛋白已被证明反向Xa在健康志愿者的抑制因素。方法:在这个多中心,前瞻性,非盲、单一群体研究中,我们评估了67后18小时内患者急性出血主要管理因素Xa抑制剂。患者所有收到的丸andexanet后跟2小时输液的药物。患者评估措施的变化anti-factor Xa活动和评估临床止血功效12小时期间。随后所有患者随访30天。47的功效人口患者的基线值anti-factor Xa活动至少75毫微克每毫升(或> / = 0.5 IU每毫升的接收伊诺肝素),在裁定已经确认出血严重程度。结果:患者的平均年龄为77岁;大多数患者有实质性的心血管疾病。主要是胃肠道或颅内出血。平均(+ / -标准差)时间从急诊室表示管理andexanet丸是4.8 + / - -1.8小时。 After the bolus administration, the median anti-factor Xa activity decreased by 89% (95% confidence interval [CI], 58 to 94) from baseline among patients receiving rivaroxaban and by 93% (95% CI, 87 to 94) among patients receiving apixaban. These levels remained similar during the 2-hour infusion. Four hours after the end of the infusion, there was a relative decrease from baseline of 39% in the measure of anti-factor Xa activity among patients receiving rivaroxaban and of 30% among those receiving apixaban. Twelve hours after the andexanet infusion, clinical hemostasis was adjudicated as excellent or good in 37 of 47 patients in the efficacy analysis (79%; 95% CI, 64 to 89). Thrombotic events occurred in 12 of 67 patients (18%) during the 30-day follow-up. CONCLUSIONS: On the basis of a descriptive preliminary analysis, an initial bolus and subsequent 2-hour infusion of andexanet substantially reduced anti-factor Xa activity in patients with acute major bleeding associated with factor Xa inhibitors, with effective hemostasis occurring in 79%. (Funded by Portola Pharmaceuticals; ANNEXA-4 ClinicalTrials.gov number, NCT02329327 .).
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